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Observational Study of CTC and cfDNA/RNA in Metastatic Breast Cancer

This study is looking at whether a test called CellSearch Circulating Tumor Cells (CTC) can help doctors make better decisions about treatment and monitoring for metastatic breast cancer (MBC). The CellSearch test looks at the number of CTCs and the presence of certain markers like HER2, Estrogen Receptor (ER), and programmed death-ligand 1 (PD-L1) on these cells. It also involves analyzing cell-free DNA/RNA (cfDNA/RNA). You may be able to join if you have MBC and are either HR+/HER2 negative or triple negative before starting your first treatment, or if you are HER2+ before starting your second treatment or later. The study will measure if doctors find the results from these tests helpful in guiding your care. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 187 participants. It will collect information about the CellSearch CTC test and cfDNA/RNA results alongside your regular medical care.
What's involved
You will have blood samples collected at the start of the study and before your first restaging visit. Additional blood samples may be collected at later restaging visits.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of the study is measured at 3-4 months, which suggests a follow-up period around this timeframe.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06833853

A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients

Recruiting
Not specifiedAges 18+Observational
Menarini Silicon Biosystems, INC
~187 participants
Updated 2026-03-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.
Measured over 3-4 months

Conditions

Metastatic Breast Cancer (MBC)

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Marija Balic, MD, PhD, MBA · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Marija Balic, MD, PhD, MBA
[email protected]
800-533-8762
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease.
HR+/HER2 negative or triple negative (TN) subjects prior to starting first line therapy or beyond in the metastatic setting.
Subject must have the CTC HER2, ER, PD-L1, and cfDNA/RNA tests ordered during routine patient care.
Age \> 18 years.

Exclusion

Participant is pregnant.
Inability to provide blood samples based on the judgment of the treating physician.

What this trial measures

  • The percentage of subjects for which the providers indicated positive impact of the cfDNA/RNA, CTC enumeration, and CTC expression results.3-4 months

    The percentage of subjects for which the providers indicated positive impact on treatment decisions or response assessment of the cfDNA/RNA, CTC enumeration, and CTC expression assessments.CTC enumeration, CTC biomarker expression, and cfDNA/RNA results in subjects with MBC.